Medical Device and Pharmaceuticals Quality Management Expert Witness

Expertise

• Quality assurance, clinical research and regulatory affairs to assist in quality systems improvements, product development, and marketing approval of medical products.
• Quality management for medical devices, pharmaceuticals, and biologicals.
• GLP, cGMP, GCP, ISO-13485 and ISO-9000 regulations as they apply to quality systems audits to assure compliance with regulations and standards.

Expert Witness Experience

• Five cases, one court testimony.
• Assisted in the reversal of three Federal Court consent decrees.

Experience

Undisclosed Company, Independent Consultant, 2001 - Present

• International engagements include Croatia, Canada, Netherlands, and Taiwan.
• Assist medical device, pharmaceutical, and biological firms as well as contract laboratories to develop and improve their quality systems.
• Gained approval for a device manufacturer to resume production and sales following regulatory closure.
• Assisted a major pharmaceutical company identify problems in their clinical development program that resulted in approval of a multi-billion dollar product.

Regulatory Affairs and Clinical Research Consultant

• Servicing the Medical Products industry.
• Provided services for numerous pharmaceutical, device, cosmetic and medical product companies.

Flemington Pharmaceutical Corporation, Flemington, NJ, 1998 - 2001

Vice President of Product Development

• Responsible for Product Development and Quality Assurance, with emphasis on formulations which were designed to deliver rapid blood molecule absorption.
• This encompassed analytical methods development, contract manufacturing and testing, clinical trials for licensing and product submissions, resulting in one approved product.

Medical Development Quality Associates, Lenexa, KS, President, 1992 - 1998

• Successful execution in clinical research, quality assurance, regulatory affairs, ISO-9000 compliance to assist in development, marketing approval and maintenance of medical device products.
• Provide technical training in GCP, GLP, cGMP and ISO-9000.
• Conduct audits to assure compliance with regulations and standards.
• Major clients: Warner-Lambert Co., Hoechst-Marion-Roussel, Inc., Procter & Gamble, Battelle Laboratories, Novartis Pharmaceuticals, Sarnoff Research Institute, Government of Pakistan, and Centeon Pharmaceutical Products.
• Assisted in the reversal of three Federal Court consent decrees.

Oread Laboratories, Inc., Lawrence, KS, Manager of Regulatory Affairs, 1991 - 1992

• Managed quality assurance of laboratory services, including GLP and GMP compliance.
• Supervised the IND development, analytical testing, contract manufacturing, clinical trials and licensing of an approved drug for neonates.
• Developed client confidence, resulting in 30% growth in staff and new contracts.

Pharmaceutical Consultants, Inc., Leawood, KS, Director of Corporate Development, 1989 - 1990

• Directed all daily activities of clinical research and regulatory affairs staff of contract clinical research organization.
• This included numerous projects for domestic and international pharmaceutical and biological products clients.
• Additional responsibilities encompassed identification of new opportunities, bids for contract, budget negotiations and technical/regulatory consulting.
• Staff increased by over 200% in eighteen months.

Martec Pharmaceutical, Kansas City, MO, Director of Clinical Research, 1988 - 1989

• Directed all aspects of clinical development of ethical and generic drugs.
• Clinical development protocol design, investigator selection, budget preparation, data review, clinical reports, selection of contract research organizations, and supervision of study monitoring.
• Interacted with all other departments to assure integrity of products and quality of regulatory submissions.
• Clinical research therapies included cardiology, rheumatology, gastroenterology and psychiatry.

Seton Company, Malvern, PA, Director of Regulatory Affairs/Quality Assurance, 1984 - 1987

• Directed all regulatory and quality assurance activities for five company divisions including submissions to federal and state agencies.
• Oversaw pre-clinical and clinical trials for new medical devices.
• Supervised manufacturing of all biologically-based products.
• Monitored bio-products research to ensure validity of procedures and equipment.
• Prevented the loss of a major customer by developing analytical support, manufacturing capabilities, and credibility to produce acceptable components for wound dressings.

Janssen Pharmaceuticals, Inc., Piscataway, NJ, 1976 - 1984

Positions held

• Director of Clinical Quality Assurance
• Director of Clinical Research
• Senior Clinical Research Associate

Responsibilities

• Identified an invalidating flaw in an NDA, which prevented the rejection of the application.
• Directed the activities of four research groups working on domestic and international drug development. This encompassed 12 new chemical entities, seven of which have been approved in the U.S.
• Supervised a staff of 16 and controlled an annual budget exceeding $2 million.
• Clinical research activities included immunology, rheumatology, oncology, cardiology, mycology, anesthesiology, gastroenterology, and allergology.

Harleco, Division of American Hospital Supply Corp., NJ and PA, 1970 - 1976

Positions held

• Compliance Coordinator, Research and Development
• Senior Research Chemist

Responsibilities

• Managed all documentation for a line of 400 diagnostic products.
• Established expiration dates for all company products.
• Developed and patented an in vitro test reagent in various packaged forms.
• Adapted established reagents to meet defined packaging requirements for a new clinical chemistry analyzer.
• Initiated and managed new product clinical research testing program.

Educator: National and International

• Good Laboratory Practices for Pre-Clinical Testing, Berlin, German
• Course Director: Good Laboratory Practices for the Center for Professional innovation and Education, Inc., Malvern, PA
• Center for Professional Advancement, Course Director for Good Laboratory Practices, Instructor for Quality Management.
• Part-time Lecturer at Univ. of Missouri, College of Pharmacy.
• Part-time Lecturer at the Business and Industry Institute, Johnson County Community College, Overland Park, KS.

Honors & Publications

Credentials

Certifications

• Regulatory Affairs Professional Society Certification
• Certified ISO-9000 Lead Assessor(IRCA)

Continued Education and Training

• Design and Conduct of Stability Studies for Developing Product Expiration Dates
• Design and Conduct of Clinical Trials
• Preparation and Filing of IND's and NDA'S
• Processes and Documentation for Sterile Products
• FDA Requirements for Health Products Derived from Biotechnology
• Teleconference from the Juran Institute on Total Quality Management
• ISO-9000 Lead Assessor Course and Examination
• FDA/FDLI Video Teleconference-The 510k Process
• Numerous courses on Good Clinical Practices

Academic and Professional Affiliations

• American Society for Quality Control (General and Auditing Divisions)
• Regulatory Affairs Professional Society
• American Diabetes Association
• SynVax Pharmaceuticals, Inc, Board Member

Education

Ph.D. Pharmaceutics, Temple University, Philadelphia, PA

M.A. Organic Chemistry, Temple University, Philadelphia, PA

B.S. Chemistry, Albright College, Reading, PA